3. INTRODUCTION
DEFINITION:
The term parenteral has been derived from
greek word
PARA ENTERON - outside the intestine
.
Parenterals are sterile preparations intended for
administration under or through one or more layers
of skin or mucous memberane .
4. TYPES
BASED ON FORMULATION
INJECTIONS : It contains sterile solutions and
prepared by dissolving the active ingredient and
other substances in water for injection or other
suitable non aqueous base .
INFUSIONS : These preparation are free from
bacterial endotoxins or pyrogens and are turned
isotonic with blood.
5. POWDER FOR INJECTION :
These are solid compounds that are
distributed in their final volume when container or vital
are shaken to form a clear particle .
CONCENTRATED SOLUTION FOR INJECTION:
These are diluted with water for injection
before injected through IV route .
IMPLANTS :
The solid sterile preparations are implanted in
the tissue in order to release the active ingredient for
long periods .
6. BASED ON DOSE
SINGLE DOSE PREPARATIONS :
These can be used only once .
Contains sufficient quantity.
Administration of volume specified on the
label
MULTI DOSE PREPARATIONS :
Multi dosing , chances of contamination is less
because it contains antimicrobial preservative
in appropriate conc.
Preservative not exceed than 30ml .
7. ADVANTAGES
They are free from pyrogens .
Low toxicity as compared to solid dosage forms .
100% Bioavailability .
No chance of missing dose .
Unconcious patients are also administered by
physician .
8. DISADVANTAGES
High cost as compared to solid dosage form
.
Requirement of trained person for
administration
Highly risk if any mistakes happens at any
point.
Real or physiological pain associated while
inject
18. * VEHICLES
AQUEOUS VEHICLE :
Water for injection :
Most commonly used solvent in large scale
manufacturing.
Not sterilized and free from pyrogens .
It is intended to be used within 24hrs after collection
.
Total solid contents not more than 1mg/100ml .
19. Sterile water for injection :
It must be pyrogen free .
Endotoxin level is not more than 0.25 USP .
Single dose container not larger than 1 liter .
Bacteriostatic water for injection :
One or more suitable antimicrobial agents .
It is packaged in prefilled syringes or in vials .
Not more than 30 ml of water .
20. Non –Aqueous vehicle :
They should be .,
Non-irritant .
Non-toxic .
Pharmacologically inert .
Non-senstising .
Metabolise easily .
Less viscous to allow syringability .
eg: ethyl oleate , isopropyl myristate ,
benzyl benzoate , dimethylacetamide
21. ADDITIVES
Solubilizing agents :
Maintain the solubility of slightly soluble
drugs by increasing their solubility .
( EX ; polysorbates , PEG 40 , ethanol )
Anti-oxidants :
The substances that act against oxidants .
(EX ; thiourea , ascorbic acid )
22. Buffering agents :
Formulations must be maintain the intended
Ph.
(Eg; acetone ,citrate ,phosphate )
Antimicrobial agents :
Used for prevention of microbes in multiple
packaging .
( Eg; phenol or chlorobutanol )
Chelating agents :
Form complexes with the metal ion and
dissolve in the solvent , thus preventing the
metal ion from interferring in the manufacturing
process .
(Eg; EDTA )
23. IMPORTANCE OF
ISOTONICITY
It is important because if the solution is isotonic
with blood , the possibility of the product
penetrating the RBC’s and causing hemolysis is
reduced .
In hypotonic solution ( 0.2% w/v of NaCl ),
water diffuses into the RBC’s causing swell and
burst i.e., hemolysis .
In hypertonic solution ( 2 % w/v of NaCl),
water diffuses out of RBC’s causing them to
shrink .
In isotonic solution ( 0.9 % w/v of NaCl
solution), that maintains their tonicity of RBC .
